From the April 2016 issue of HealthCare Business News magazine
N o n - i n v a s i v e therapeutic ultrasound, with its 18 distinct bio-effects on tissue, is now approved or under investigation to treat nearly 60 conditions ranging from neurological disorders to cancers, pain and even hypertension.
Over these past two years, the field has experienced unparalleled progress, and recent research advances have brought us to the tipping point for the technology to transform from research to clinical use. The FDA recently approved two prostate devices, giving patients in the United States access to a therapy that has been available in several other countries for years.
The blood-brain barrier has been opened to deliver chemotherapy directly to the brain and demonstrate the potential of treating other diseases including Alzheimer’s. We are on the cusp of starting the first clinical trials to enhance cancer immunotherapy which could demonstrate a critical role for focused ultrasound in combination with promising immunotherapies to treat advanced cancer.
And the FDA is currently reviewing a focused ultrasound system for noninvasive, precise ablation of the brain to treat essential tremor. Once approved, this would open the door to treating Parkinson’s and other movement disorders, as well as psychiatric disorders and brain tumors. A technology once referred to as “medicine’s best kept secret” is poised to become a major therapeutic tool with the ability to impact the lives of countless individuals.
Expanding patient access and growing the U.S. market (for prostate)
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Focused ultrasound has been used worldwide to treat more than 50,000 men with prostate cancer over the past 20 to 25 years. Yet despite approvals in Europe and elsewhere, men in the United States have had to travel overseas to access this less invasive and non-ionizing treatment. But men who want to avoid surgery and radiation now have a new option — the FDA recently approved two focused ultrasound systems (Sonablate from Sonacare and Ablatherm from EDAP) for prostate tissue ablation.
This is great news for patients who desire treatment that is less invasive and may offer fewer complications and quicker recovery than traditional methods. FDA approval of two new prostate systems is a huge step forward for the field in the U.S. Because of the potential for fewer complications and side effects, many prostate patients will pay out-of-pocket for focused ultrasound treatment. This helps to build momentum for clinical use as well as eventual widespread reimbursement and commercial success. Knowing that patient demand will be robust, urologists are investing in the technology — more than 10 practices have acquired Sonacare or EDAP’s systems in the past few months since FDA approval.